Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369226
Status:
COMPLETED
Last Update Posted:
2013-07-25
First Post:
2006-08-24
Brief Title:
Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease GVHD After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase III Trial of Bortezomib Velcade in Addition to Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease GVHD After Mismatched Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if Velcade also known as bortezomib can help prevent graft versus host disease GVHD developing after transplantation This is done by using a combination of three immune suppressive medications Velcade tacrolimus and methotrexate Stem cell transplantation is one of the options for patients with cancer of the blood or blood forming organs Recently allogeneic stem cell transplants have been performed using lower doses of chemotherapy and radiotherapy non-myeloablative or mini transplants GVHD is a significant problem that may occur even after mini transplantations Information from other research studies suggests that Velcade may help to reduce the risk of developing GVHD when given early after transplantation
Detailed Description:
In this study we are looking for the highest dose of Velcade that can be given to people safely when given with tacrolimus and methotrexate Not everyone who participates in the study will receive the same amount of the study drug The dose the participant will receive depends upon the number of subjects enrolled on the study and how well they have tolerated their doses of the drug
Before Transplant In addition to the chemotherapy drugs fludarabine and busulfex for the participants non-myeloablative transplant they will also start taking tacrolimus orally three days before their transplant
After Transplant Medication Methotrexate Intravenously on days 1 3 6 11 after transplant for a total of 4 doses Tacrolimus Continue taking orally once daily Velcade Intravenously on days 1 4 7 after transplant a total of 3 doses Filgrastim Subcutaneous injection daily starting the day after transplant and continuing until the participant blood counts have recovered
After Transplant Physical Exams Tests Participants will have physical exams and blood tests every week for 1 month After 1 month a none marrow biopsy will be performed to look for evidence of the donors cells in the participants bone marrow
Following the 1 month period of time participants will be seen every few weeks Another bone marrow biopsy as well as blood tests will be taken 3-4 months after the transplant to review the disease status At this point participants will come into the clinic about every 3 months or as determined by their physician for about one year
While the study ends at 12 months after transplant we would like to keep track of the participants medical condition for the rest of their life
Before Transplant In addition to the chemotherapy drugs fludarabine and busulfex for the participants non-myeloablative transplant they will also start taking tacrolimus orally three days before their transplant
After Transplant Medication Methotrexate Intravenously on days 1 3 6 11 after transplant for a total of 4 doses Tacrolimus Continue taking orally once daily Velcade Intravenously on days 1 4 7 after transplant a total of 3 doses Filgrastim Subcutaneous injection daily starting the day after transplant and continuing until the participant blood counts have recovered
After Transplant Physical Exams Tests Participants will have physical exams and blood tests every week for 1 month After 1 month a none marrow biopsy will be performed to look for evidence of the donors cells in the participants bone marrow
Following the 1 month period of time participants will be seen every few weeks Another bone marrow biopsy as well as blood tests will be taken 3-4 months after the transplant to review the disease status At this point participants will come into the clinic about every 3 months or as determined by their physician for about one year
While the study ends at 12 months after transplant we would like to keep track of the participants medical condition for the rest of their life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| X05175 | None | None | None |